MAUDE Adverse Event Report: JJGC S.A. GM Helix Implant,Ti,3.5X8; Endosseous Dental Implant

Catalog Number	109.943
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Pain (1994); Fibrosis (3167)
Date of Event	07/17/2026
Type of Reportable Event	Serious Injury

• Brand Name: GM Helix Implant,Ti,3.5X8
• Common Device Name: Endosseous Dental Implant
• Manufacturer (Section D): JJGC S.A.; av. juscelino kubitschek de; oliveira, 3291 cic; curitiba PR 81270 -200; BR 81270-200
• Manufacturer (Section G): JJGC S.A.; av. juscelino kubitschek de; oliveira, 3291 cic; curitiba PR 81270 -200; BR 81270-200
• Manufacturer Contact: jennifer jackson ; 60 minuteman road; andover, MA 01810 ; +1(978)747-2509
• MDR Report Key: 50826895
• Report Number: 3008261720-2026-005063
• Device Sequence Number: 18810816
• Product Code: DZE
• UDI-Device Identifier: 07899878024149
• UDI-Public: 07899878024149
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K163194
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 109.943
• Device Lot Number: TNEA1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male